Risk Management and Analysis in Medical Device Manufacturing using PFMEA

Process Tools Including Process Flow, PFMEA, Control Plans and Work Instructions

Seminar Content

This two-day hands-on seminar is intended to offer insight into, and hands-on experience with, the linkages between various aspects of the Risk Management process. Specifically, the development and linkage of Process Flows, PFMEAs, Control Plans and shop floor documentation are addressed. This information can be used to achieve process standardization and improvement.

This class includes breakout exercise sessions using an example of a Medical Device sub-assembly project and product launch. This running example will be used throughout the five-day Risk Management and Analysis in Medical Device Manufacturing Series. (This also includes: ISO 14971:2009 Risk Management for Medical Devices Overview and Practical Risk Management using DFMEA).

Who Should Attend

  • Program Managers
  • Project Managers
  • Quality Managers
  • Process Engineers
  • Enhanced FAI/AQP Coordinators
  • AQP Team Members
  • All other Risk Management personnel

Recommended Training and/or Experience

Participants should possess a working knowledge of quality systems and methodologies.

Seminar Materials

Each participant will receive a seminar manual and a workbook including all team breakout exercises.

Seminar Goals

  • Gain knowledge and understanding in:
    • Process Flows
    • Linkages between Process Flows, PFMEAs, Control Plans and Work Instructions
    • Linkages between PFMEAs and S/DFMEAs
    • Using FMEA as an analytical process
    • Characteristics Matrix
    • Process FMEAs and Control Plans

Seminar Outline

  • FMEA Review
  • Putting an FMEA Together
  • PDFMEA Prerequisites
    • Breakout Exercise: Customers & Functional Requirements
    • Breakout Exercise: Process Flow
  • Developing the PFMEA
    • Breakout Exercise: PFMEA Steps, Functions, Requirements and FMs
    • Breakout Exercise: PFMEA Causes
    • Breakout Exercise: PFMEA Prevention/Detection Controls, Occurrence & Detection Index
    • Breakout Exercise: PFMEA Effects, Severity Indices and RPN
  • Using PFMEA to Improve the Process
    • Breakout Exercise: PFMEA Actions
  • FMEA and the Product Realization Process
  • Evaluating a Process FMEA
    • Breakout Exercise: Developing a Component PFMEA Process
  • Control Plans
    • Breakout Exercise: Control Plans
  • Work Instructions
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